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FDAFebruary 1, 2022device

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

What to do

FDA enforcement status: Ongoing

Brands named

mevion medical systemsmevionmevion medical

UPCs

0086436600010000864366000124

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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